01 1ACS DOBFAR SPA
02 1AVT (Shanghai)
03 2Ajinomoto Company
04 2CordenPharma
05 1Mitsubishi Tanabe Pharma
06 2Orchid Pharma
01 1ARGININE
02 2ARGININE (STERILE BULK)
03 1CEFEPIME & ARGININE (STERILE BULK)
04 1CEFEPIME/L-ARGININE STERILE BLEND
05 3L-ARGININE
06 1L-ARGININE BASE
01 1China
02 2Germany
03 2India
04 1Italy
05 3Japan
01 7Active
02 2Inactive
01 3Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22918
Submission : 2009-06-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39434
Submission : 2024-04-30
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-04
Pay. Date : 2020-11-30
DMF Number : 31646
Submission : 2017-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39677
Submission : 2024-04-08
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-04
Pay. Date : 2014-05-23
DMF Number : 28191
Submission : 2014-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10131
Submission : 1989-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1929
Submission : 1972-05-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18843
Submission : 2005-10-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-09
Pay. Date : 2021-08-04
DMF Number : 18923
Submission : 2005-10-31
Status : Active
Type : II
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